Trial Outcomes & Findings for Ultrasound Efficacy in Moderate Rheumatoid Arthritis (NCT NCT04662359)

Last Updated: 2024-04-16

Results Overview

The primary outcome variable is the proportion of patients with low synovitis scores, which will be determined by the ultrasound assessment. These scores will also be compared to other measures of disease activity. The investigators will be using the EULAR-OMERACT (European League Against Rheumatism - Outcome Measures in Rheumatology) combined scoring system for grading synovitis in rheumatoid arthritis. Each joint is scored from 0-3 with higher scores indicating higher inflammatory activity. Patients with scores of 1 or below in all measured joints are considered to have low synovitis scores.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

The outcome is assessed at the time of ultrasound

Results posted on

2024-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasound Assessment of Rheumatoid Arthritis Severity All patients will receive an ultrasound scan to assess the severity of their arthritis. This scan will then be placed in their medical record to allow their rheumatologist to utilize the scan when making treatment recommendations. Ultrasound Assessment: Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Efficacy in Moderate Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound Assessment of Rheumatoid Arthritis Severity n=18 Participants All patients will receive an ultrasound scan to assess the severity of their arthritis. This scan will then be placed in their medical record to allow their rheumatologist to utilize the scan when making treatment recommendations. Ultrasound Assessment: Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Rheumatoid arthritis disease duration	14 years STANDARD_DEVIATION 12 • n=5 Participants

PRIMARY outcome

Timeframe: The outcome is assessed at the time of ultrasound

Outcome measures

Outcome measures
Measure	Ultrasound Assessment of Rheumatoid Arthritis Severity n=18 Participants All patients will receive an ultrasound scan to assess the severity of their arthritis. This scan will then be placed in their medical record to allow their rheumatologist to utilize the scan when making treatment recommendations. Ultrasound Assessment: Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
Low Synovitis Scores	1 Participants

SECONDARY outcome

Timeframe: This measure is assessed after ultrasound results are available (1-2 weeks after ultrasound is performed) based on provider survey

The secondary outcome will be the number of patients for which the ultrasound information changed the treatment recommendation of the clinical provider.

Outcome measures

Outcome measures
Measure	Ultrasound Assessment of Rheumatoid Arthritis Severity n=18 Participants All patients will receive an ultrasound scan to assess the severity of their arthritis. This scan will then be placed in their medical record to allow their rheumatologist to utilize the scan when making treatment recommendations. Ultrasound Assessment: Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
Treatment Recommendations	6 Participants

Adverse Events

Ultrasound Assessment of Rheumatoid Arthritis Severity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael George

University of Pennsylvania

Phone: 215-662-2454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place